Top Pick of the Day: ORMP

Oramed Pharmaceuticals (ORMP) reported the successful conclusion of its meeting with the FDA with regard to its drug candidate ORMD-0801. The company reported that the FDA gave clear guidance that the regulatory pathway for submission of ORMD-0801 will be a Biologics License Application. This implies that post approval, the drug will have a full 12 years of marketing exclusivity. If the product is approved for pediatric patients as well, then additional six months of exclusivity may be granted. The company plans to comply with the FDA suggestion of initiating a three-month trial in patients with type 2 diabetes to evaluate the effect of ORMD-0801 on HbA1c, the main FDA registrational endpoint, later this year.
The company stock reacted positively to the news and gained over 15 percent in its pre-market session.

Focus Ticker: INSM

Insmed (INSM) stock jumped over 100 percent in the pre-market session as the company announced its positive top line results from a a Phase 3 clinical trial, CONVERT, assessing ALIS (amikacin liposome inhalation suspension) in adult patients with treatment-resistant nontuberculous mycobacterial lung disease caused by mycobacterium avium complex. The trial met its primary endpoint which was of a tatistically valid proportion of patients in the ALIS + guideline-based therapy (GBT) cohort achieving culture conversion by month 6 compared to GBT alone. The company plans to pursue accelerated approval in the U.S. where the drug has Breakthrough Therapy, Fast Track and QIDP status.
The company stock had lost 7 percent of its value in the past 12 months.

Sector News

Merck (MRK) announced that its Keytruda has been approved by the European Commission as monotherapy for the treatment of adult patients with locally advanced or metastatic urothelial carcinoma (UC) (bladder cancer) who have received prior platinum-based chemo or adult UC patients who are ineligible for cisplatin-containing chemo.

BioCryst Pharmaceuticals (BCRX) announced the final results from its Phase 2 APeX-1 study assessing BCX7353 as a preventative treatment to reduce the frequency of attacks in patients with hereditary angioedema. The final results that the treatment with BCX7353 reduced HAE attacks as much as 90% compared to placebo.